510(k) K130217 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 20, 2013 |
| Received | Jan 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2020 | OrthoPediatrics Corp OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction Terminated |
MBI | None listed |
| Aug 29, 2014 | OrthoPediatrics Corp ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm
Product Usage:
The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL recon Terminated |
MBI | None listed |
| Dec 26, 2013 | OrthoPediatrics Corp OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.